A Pilot Investigation of Ciclesonide When Administered as a Hypotonic Versus an Isotonic Formulation of Ciclesonide Nasal Spray
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ClinicalTrials.gov Identifier: NCT00793858 |
Recruitment Status
:
Withdrawn
(Cost prohibitive and company withdrew support.)
First Posted
: November 19, 2008
Last Update Posted
: June 7, 2013
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Allergic Rhinitis | Drug: placebo, isotonic ciclesonide, hypotonic ciclesonide | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 0 participants |
Allocation: | Randomized |
Intervention Model: | Single Group Assignment |
Masking: | Single (Participant) |
Primary Purpose: | Basic Science |
Official Title: | A Pilot Investigation of the Nasal Mucosal Absorption, Retention, and Metabolism of Ciclesonide When Administered as a Hypotonic Versus an Isotonic Formulation of Ciclesonide Nasal Spray When Each Formulation Is Administered to Currently Symptomatic Patients (18 Years or Older) With Documented Perennial Allergic Rhinitis (PAR). |
Study Start Date : | February 2009 |
Estimated Primary Completion Date : | September 2009 |

Arm | Intervention/treatment |
---|---|
Active Comparator: 1
placebo in left nostril, isotonic ciclesonide in right
|
Drug: placebo, isotonic ciclesonide, hypotonic ciclesonide
200mcg/nostril
|
Active Comparator: 2
hypotonic ciclesonide in left nostril, placebo in right
|
Drug: placebo, isotonic ciclesonide, hypotonic ciclesonide
200mcg/nostril
|
Active Comparator: 3
hypotonic ciclesonide in right and left nostrils
|
Drug: placebo, isotonic ciclesonide, hypotonic ciclesonide
200mcg/nostril
|
Active Comparator: 4
isotonic ciclesonide in both right and left nostrils
|
Drug: placebo, isotonic ciclesonide, hypotonic ciclesonide
200mcg/nostril
|
Placebo Comparator: 6
placebo in both right and left nostrils
|
Drug: placebo, isotonic ciclesonide, hypotonic ciclesonide
200mcg/nostril
|
Active Comparator: 5
isotonic ciclesonide in left nostril and hypotonic ciclesonide in right
|
Drug: placebo, isotonic ciclesonide, hypotonic ciclesonide
200mcg/nostril
|
- levels of ciclesonide in biopsy tissue [ Time Frame: 2 hours post study drug administration ]

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Ages Eligible for Study: | 18 Years to 65 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Males and females 18 years of age or older.
- History of perennial allergic rhinitis for at least 1 year prior to screening.
- Positive skin test to perennial allergen.
Exclusion Criteria:
- Physical signs or symptoms suggestive of renal, hepatic or cardiovascular disease.
- Pregnant or lactating women.
- Upper respiratory infection within 14 days of study start.
- Active asthma requiring treatment with inhaled or systemic steroids.
- Use of any form of nasal spray during the previous month.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00793858
United States, Illinois | |
University of Chicago Medical Center | |
Chicago, Illinois, United States, 60637 |
Responsible Party: | University of Chicago |
ClinicalTrials.gov Identifier: | NCT00793858 History of Changes |
Other Study ID Numbers: |
16651A (SEP 1) |
First Posted: | November 19, 2008 Key Record Dates |
Last Update Posted: | June 7, 2013 |
Last Verified: | June 2013 |
Additional relevant MeSH terms:
Rhinitis Rhinitis, Allergic Nose Diseases Respiratory Tract Diseases Respiratory Tract Infections Otorhinolaryngologic Diseases Respiratory Hypersensitivity Hypersensitivity, Immediate |
Hypersensitivity Immune System Diseases Ciclesonide Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Anti-Allergic Agents |